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Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory
Session Chair(s)
Bennett Levitan, MD, PHD
Executive Director, Benefit-Risk Assessment / Epidemiology
Johnson & Johnson, United States
Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.
Learning Objective : (1) Identify examples of how patient input informed regulatory agency decision-making; (2) Appraise models of patient engagement during drug development; (3) Integrate patient engagement strategies into industry programs to inform clinical and regulatory strategy
Speaker(s)
The Voice of the Patient: Setting the Therapeutic Context for Regulatory Decision Making
James Valentine, JD, MHS
Hyman, Phelps & McNamara, PC, United States
Director
Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
Lesley Wise, PHD, MSC
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Advancing the Science of Patient Inputs in the Regulatory Setting
Telba Irony, PHD, MS, MSC
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences